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
K891895Substantially Equivalent

Surgical Loupes

Zinnanti Surgical Instruments, Inc., Chatsworth CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891895 is the FDA 510(k) clearance record for SURGICAL LOUPES, a class I device, cleared for Zinnanti Surgical Instruments, Inc. on under FDA product code FSP (Loupe, Diagnostic/Surgical). FDA records list 76 510(k) clearances for Zinnanti Surgical Instruments, Inc., from to . As of , FDA records show no recalls naming K891895.

Clearance record

Decision date
Received
(19 days to decision)
Product code
FSP Loupe, Diagnostic/Surgical
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Zinnanti Surgical Instruments, Inc. 21540-B Prairie St., Chatsworth CA
Third party review
No

Clearances, product code FSP

Trailing 12 months

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

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