510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950560Substantially Equivalent

Saline Solutine, Sterile

Busse Hospital Disposables, Hauppauge NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950560 is the FDA 510(k) clearance record for SALINE SOLUTINE, STERILE, a class I device, cleared for Busse Hospital Disposables, Inc. on under FDA product code IGE (Solution, Formalin Ammonium Bromide). FDA records list 35 510(k) clearances for Busse Hospital Disposables, Inc., from to . As of , FDA records show no recalls naming K950560.

Clearance record

Decision date
Received
(111 days to decision)
Product code
IGE Solution, Formalin Ammonium Bromide
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Applicant
Busse Hospital Disposables, Inc. P.O. Box 11067, Hauppauge NY
510(k) summary
Statement
Third party review
No

Clearances, product code IGE

Trailing 12 months

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

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