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
K980849Substantially Equivalent

Surgin Kit

Surgin Surgical Instrumentation, Inc., Tustin CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980849 is the FDA 510(k) clearance record for SURGIN KIT, a class II device, cleared for Surgin Surgical Instrumentation, Inc. on under FDA product code MSR (Tubing, Replacement, Phacofragmentation Unit). FDA records list 23 510(k) clearances for Surgin Surgical Instrumentation, Inc., from to . As of , FDA records show no recalls naming K980849.

Clearance record

Decision date
Received
(154 days to decision)
Product code
MSR Tubing, Replacement, Phacofragmentation Unit
Regulation
21 CFR 886.4150
Device class
Class II
Review panel
Ophthalmic
Applicant
Surgin Surgical Instrumentation, Inc. 14762 Bentley Cir., Tustin CA
510(k) summary
Statement
Third party review
No

Clearances, product code MSR

Trailing 12 months

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

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