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
K950250Substantially Equivalent for Some Indications

Med-Surg Suture Washer

Medical Surgical, Inc., Minneapolis MN / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K950250 is the FDA 510(k) clearance record for MED-SURG SUTURE WASHER, a class II device, cleared for Medical Surgical, Inc. on under FDA product code HWC (Screw, Fixation, Bone). FDA records list one 510(k) clearance for Medical Surgical, Inc. As of , FDA records show no recalls naming K950250.

Clearance record

Decision date
Received
(114 days to decision)
Product code
HWC Screw, Fixation, Bone
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Medical Surgical, Inc. 5924 7th St., NE, Minneapolis MN
Third party review
No

Clearances, product code HWC

Trailing 12 months
21 clearances under product code HWC in the twelve months to October 2026, May 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code HWC, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20262
April 20263
May 20264
June 20262
July 20261
August 20263
September 20264
October 20260