BIOPSY TRAY— 510(k) K970152

Name: FDA 510(k) clearance K970152
Creator: U.S. Food and Drug Administration
Published: 1997-03-05

Substantially Equivalent for Some Indications

Medcare Medical Group, Inc.

FDA 510(k) clearance K970152 for BIOPSY TRAY, Substantially Equivalent for Some Indications on 1997-03-05. Applicant: Medcare Medical Group, Inc.. Device class: 2.

Clearance details

Applicant: Medcare Medical Group, Inc.
Product code: Code FRG
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 1997-01-16
Decision date: 1997-03-05
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: East Swanzey, NH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FRG

view all

K261897 — HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology +3 more2026-07-02
K252823 — Dukal Crepe Paper Sterilization Wrap2026-05-28
K253454 — HALYARD* ONE-STEP* Sterilization Wrap +3 more2026-05-18
K251347 — Sterilization Pouch/Roll2026-01-28
K251177 — Self-Seal Sterilization Pouch and Roll2025-12-12

More clearances from Medcare Medical Group, Inc.

view all

K973497 — HUBERLOC1998-01-13
K962849 — CATHETER INSERTION TRAY1996-10-07
K961075 — MEDCARE REGIONAL ANETHESIA KIT1996-09-06
K962328 — SINGLE USE INSTRUMENT TRAY1996-08-09
K962527 — GENERAL PURPOSE DENTAL TRAY1996-08-01

Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.