510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881312Substantially Equivalent

Laminaria

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

K881312 is the FDA 510(k) clearance record for LAMINARIA, a class II device, cleared for Busse Hospital Disposables, Inc. on under FDA product code HDY (Dilator, Cervical, Hygroscopic-Laminaria). FDA records list 35 510(k) clearances for Busse Hospital Disposables, Inc., from to . As of , FDA records show no recalls naming K881312.

Clearance record

Decision date
Received
(56 days to decision)
Product code
HDY Dilator, Cervical, Hygroscopic-Laminaria
Regulation
21 CFR 884.4260
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Busse Hospital Disposables, Inc. P.O. Box 11067, Hauppauge NY
Third party review
No

Clearances, product code HDY

Trailing 12 months

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

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