510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K810187Substantially Equivalent

Auto Suture Pss Skin Stapling Instrument

United States Surgical, A Division of Tyco Healthc, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810187 is the FDA 510(k) clearance record for AUTO SUTURE PSS SKIN STAPLING INSTRUMENT, a class I device, cleared for United States Surgical, A Division of Tyco Healthc on under FDA product code KBC (Saw, Nasal). FDA records list 218 510(k) clearances for United States Surgical, A Division of Tyco Healthc, from to . As of , FDA records show no recalls naming K810187.

Clearance record

Decision date
Received
(57 days to decision)
Product code
KBC Saw, Nasal
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
United States Surgical, A Division of Tyco Healthc 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KBC

Trailing 12 months

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

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