510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770054Substantially Equivalent

Mirror, Naso-Pharynx

Welch Allyn Inc, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770054 is the FDA 510(k) clearance record for MIRROR, NASO-PHARYNX, a class I device, cleared for Welch Allyn, Inc. on under FDA product code KAI (Mirror, Ent). FDA records list 112 510(k) clearances for Welch Allyn, Inc., from to . As of , FDA records show no recalls naming K770054.

Clearance record

Decision date
Received
(8 days to decision)
Product code
KAI Mirror, Ent
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Welch Allyn, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KAI

Trailing 12 months

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

FDA records show no clearances under product code KAI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KAI, 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