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Companies / Pristine Surgical
Medical device company profile

Pristine Surgical

Single-use surgical visualization systems combining Summit arthroscopes with cloud-connected workflow software.

Medical Device ManufacturerOrthopedics & MusculoskeletalSports Medicine & Soft Tissue RepairCommercial-stage
HeadquartersπŸ‡ΊπŸ‡ΈManchester, New Hampshire, United States
FoundedNot confirmed
Commercial statusCommercially availableSelected products commercially offered; availability and indications vary by product and market.
EmployeesNot confirmed
Estimated revenueNot confirmed
Disclosed fundingUS$15 million [15]Series D (A4) Β· Mar 2022
Official websitepristinesurgical.com β†—

Company overview

Pristine Surgical develops single-use endoscopic visualization technology. Its commercial Summit arthroscope provides 4K imaging and connects with Pristine Connect software for image/video handling and inventory workflows. The company announced U.S.-wide availability in November 2023.

The commercial model centers on scopes by subscription and distribution through selected partners. The company positions this against the maintenance, reprocessing and capital requirements of reusable systems. Those economic and sustainability claims depend on facility usage, pricing and local processes.

The current leadership page identifies Rich McKillop as CEO and Chief Revenue Officer, while earlier launch announcements name previous leaders. Laparoscopy and flexible endoscopy are described as pipeline areas; their inclusion on a development roadmap does not establish commercial availability or clearance of every planned device.

[10][11][12][13][15]

Leadership

4 people
Rich McKillopChief Executive Officer & Chief Revenue Officer [12]
Gordon GoodchildChief Technology Officer [12]
Jeffrey S. AbramsChief Medical Officer [12]
Steve SegerChief Commercial Officer [12]

Products & regulatory status How does MedTechIndex get this information?

Summary

Summit/Pristine Arthroscopic Visualization System has clearance K223244 and documented commercial release. Two earlier Pristine Scope decisions are retained as history rather than assumed to cover every current Summit configuration. Laparoscopy and flexible endoscopy remain separate development areas. [10][14][4][13][12][1]

No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [8][6]

Regulatory snapshot How to read this snapshot

U.S. FDA
1
510(k) clearances
0
De Novo grants
0
PMA approvals
0
Recall events

Latest recorded source review: 2026-10-20.

Commercial portfolio snapshot

Documented commercial product families.

Single-use arthroscopic visualization

Summit / Pristine Arthroscopic Visualization System β†—

4K single-use arthroscope and connected workflow software; commercial system separated from future flexible/laparoscopic products. [10][14]

FDA-cleared

Commercially offered; exact model and country availability should be confirmed with the manufacturer.

Commercial development

Summit arthroscopy is commercial. Laparoscopy and flexible endoscopy remain pipeline areas in the reviewed company materials. [10][13]

Activity & Milestones

2 events
2023-11-27 Β· Commercialization

Full U.S. market release

Company announced broad U.S. availability after a limited rollout, including distribution through selected partners. [13]

2022-12-21 Β· Regulatory

Arthroscopic system receives clearance

FDA decision predates the January 2023 public clearance announcement. [14]

15 Cited Sources

Accessed 10/29/2026

[1] FDA 510(k) database β€” research search β†—FDA / openFDA Β· regulatory record
[2] FDA K183165 β€” Pristine Scope β†—U.S. Food and Drug Administration Β· regulatory record
[3] FDA K193161 β€” Pristine Scope β†—U.S. Food and Drug Administration Β· regulatory record
[4] FDA K223244 β€” Pristine Arthroscopic Visualization System β†—U.S. Food and Drug Administration Β· regulatory record
[5] FDA De Novo database β€” research search β†—FDA / openFDA Β· regulatory record
[7] FDA PMA database β€” research search β†—FDA / openFDA Β· regulatory record
[9] FDA UDI database β€” research search β†—FDA / openFDA Β· regulatory record
[11] Commercial subscription model and economics β†—Pristine Surgical Β· company website
[12] Current executive leadership β†—Pristine Surgical Β· company website
[13] Full U.S. market release of Summit β†—Pristine Surgical Β· company website Β· Published 2023-11-27
[14] FDA 510(k) K223244 β†—U.S. Food and Drug Administration Β· regulatory database
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