510(k) Report

FDA applicant

Pristine Surgical

Manchester, NH3 decisions2019–20220 recalls

FDA records 3 decisions for Pristine Surgical (Manchester, NH) from 2019 to 2022: 3 510(k) clearances. Most are in product codes HRX (Arthroscope) and GCJ (Laparoscope, General & Plastic Surgery). Since 2016 its 510(k)s took a median of 62 days from receipt to decision, against 61 for FDA’s reviews in the same codes and years. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Pristine Surgical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2019: 12020: 12022: 1
2019high 1 (2019) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Pristine Surgical by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HRXArthroscope2decisions
  • GCJLaparoscope, General & Plastic Surgery1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 62 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 61 days; 1 of its 3 were faster than that.

What has FDA decided for it lately?

  • K223244Pristine Arthroscopic Visualization SystemPristine Surgical · 2022
  • K193161Pristine ScopePristine Surgical · 2020
  • K183165Pristine ScopePristine Surgical · 2019

All 3 as Pristine Surgical →

Other applicant names beginning “Pristine”

FDA records each applicant name separately; these may or may not be the same firm.

Pristine Access Technologies, Ltd. 1