510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K981611Substantially Equivalent

Snap-N-Peel Introducers

Circon Corp., Santa Barbara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981611 is the FDA 510(k) clearance record for SNAP-N-PEEL INTRODUCERS, a class II device, cleared for Circon Corp. on under FDA product code KNY (Accessories, Catheter, G-U). FDA records list 6 510(k) clearances for Circon Corp., from to . As of , FDA records show no recalls naming K981611.

Clearance record

Decision date
Received
(85 days to decision)
Product code
KNY Accessories, Catheter, G-U
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Circon Corp. 6500 Hollister Ave., Santa Barbara CA
510(k) summary
Summary
Third party review
No

Clearances, product code KNY

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