Cleared Traditional

LAPSTICK LAPAROSCOPIC SPONGE STICK/ BLUNT DISSEC.

K922987 · Biosearch Medical Products, Inc. · General & Plastic Surgery

Apr 1993

Decision

305d

Days

Class 2

Risk

About This 510(k) Submission

K922987 is an FDA 510(k) clearance for the LAPSTICK LAPAROSCOPIC SPONGE STICK/ BLUNT DISSEC., a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by Biosearch Medical Products, Inc. (Somerville, US). The FDA issued a Cleared decision on April 23, 1993, 305 days after receiving the submission on June 22, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K922987 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 22, 1992
Decision Date	April 23, 1993
Days to Decision	305 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement

Device Classification

Product Code	GCJ — Laparoscope, General & Plastic Surgery
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).