510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K970372Substantially Equivalent

Gastroscope and Colonoscope Nozzle Replacement Kits

Precision Endoscopy of America, Inc., Hunt Valley MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970372 is the FDA 510(k) clearance record for GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS, a class II device, cleared for Precision Endoscopy of America, Inc. on under FDA product code FDF (Colonoscope And Accessories, Flexible/Rigid). FDA's definition for product code FDF reads: "To examine or perform procedures in the colon or rectum For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807...". FDA records list one 510(k) clearance for Precision Endoscopy of America, Inc. As of , FDA records show no recalls naming K970372.

Clearance record

Decision date
Received
(39 days to decision)
Product code
FDF Colonoscope And Accessories, Flexible/Rigid
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Precision Endoscopy of America, Inc. 10969 Mccormick Rd., Hunt Valley MD
510(k) summary
Summary
Third party review
No

Clearances, product code FDF

Trailing 12 months
5 clearances under product code FDF in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FDF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20261
June 20260
July 20261
August 20261
September 20261
October 20260