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
K770586Substantially Equivalent

Universal Mouthpiece, #750

Surgicot, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770586 is the FDA 510(k) clearance record for UNIVERSAL MOUTHPIECE, #750, a class I device, cleared for Surgicot, Inc. on under FDA product code BYP (Mouthpiece, Breathing). FDA records list 19 510(k) clearances for Surgicot, Inc., from to . As of , FDA records show no recalls naming K770586.

Clearance record

Decision date
Received
(8 days to decision)
Product code
BYP Mouthpiece, Breathing
Regulation
21 CFR 868.5620
Device class
Class I
Review panel
Anesthesiology
Applicant
Surgicot, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code BYP

Trailing 12 months

FDA records hold no clearances under product code BYP in the trailing twelve months.

FDA records show no clearances under product code BYP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BYP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260