510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K963775Substantially Equivalent

Model 8800 Aspirator

Medical Specifics, Inc., Carrollton TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963775 is the FDA 510(k) clearance record for MODEL 8800 ASPIRATOR, a class II device, cleared for Medical Specifics, Inc. on under FDA product code BTA (Pump, Portable, Aspiration (Manual Or Powered)). FDA records list one 510(k) clearance for Medical Specifics, Inc. As of , FDA records show no recalls naming K963775.

Clearance record

Decision date
Received
(188 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
Medical Specifics, Inc. 3306 Wiley Post Rd., Suite 106, Carrollton TX
510(k) summary
Statement
Third party review
No

Clearances, product code BTA

Trailing 12 months
7 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 20261