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
K950495Substantially Equivalent

Sugical Dynamics Endoscopy Irrigation Pump, Catalog #3-4000

Surgical Dynamics Ltd, Concord CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950495 is the FDA 510(k) clearance record for SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000, a class II device, cleared for Surgical Dynamics, Inc. on under FDA product code BTA (Pump, Portable, Aspiration (Manual Or Powered)). FDA records list 12 510(k) clearances for Surgical Dynamics, Inc., from to . As of , FDA records show no recalls naming K950495.

Clearance record

Decision date
Received
(92 days to decision)
Product code
BTA Pump, Portable, Aspiration (Manual Or Powered)
Regulation
21 CFR 878.4780
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Surgical Dynamics, Inc. 2575 Stanwell Dr., Concord CA
510(k) summary
Summary
Third party review
No

Clearances, product code BTA

Trailing 12 months
6 clearances under product code BTA 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 BTA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20261
May 20264
June 20260
July 20260
August 20260
September 20260
October 20260