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
K881707Substantially Equivalent

Introcular Fluid Injector

B&B Medical Assoc., Inc., Danvers MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881707 is the FDA 510(k) clearance record for INTROCULAR FLUID INJECTOR, a class II device, cleared for B&B Medical Assoc., Inc. on under FDA product code FIH (Pump, Infusion Or Syringe, Extra-Luminal). FDA records list 5 510(k) clearances for B&B Medical Assoc., Inc., from to . As of , FDA records show no recalls naming K881707.

Clearance record

Decision date
Received
(193 days to decision)
Product code
FIH Pump, Infusion Or Syringe, Extra-Luminal
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
B&B Medical Assoc., Inc. 4 Canal St., Danvers MA
Third party review
No

Clearances, product code FIH

Trailing 12 months

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

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