FDA product code GCJ: Laparoscope, General & Plastic Surgery

GCJ is the FDA product code for laparoscope, general & plastic surgery. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1,430 510(k) submissions under GCJ, 126 in the last five years, from 540 different applicants. The average 510(k) review took 115 days (median 88); 133 days on average over the last three years. FDA has posted 274 recalls for GCJ devices, 51 initiated in the last five years.

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).

Classification

Field	Value
Device name	Laparoscope, General & Plastic Surgery
Device class	Class II
Regulation	21 CFR 876.1500
Review panel	SU — General and Plastic Surgery
Medical specialty	Gastroenterology, Urology
Premarket route	510(k)

510(k) clearances per year for GCJ

Year	Clearances	Avg. review days
2017	20	85
2018	21	120
2019	15	106
2020	28	110
2021	18	136
2022	20	140
2023	31	131
2024	29	129
2025	21	137
2026	25	132

Compare with all 510(k) review times · Search every GCJ clearance

Top GCJ applicants

Applicant	Clearances	Latest
KARL STORZ Endoscopy-America, Inc.	47	2023-03-30
Origin Medsystems, Inc.	34	1999-07-30
Phx Technologies Corp.	33	1994-05-18
United States Surgical, A Division of Tyco Healthc	30	2006-09-01
Richard Wolf Medical Instruments Corp.	28	2008-05-14

535 more applicants have GCJ clearances. See the full list in Caduvo.

Most recent GCJ clearances

510(k)	Applicant	Device	Decision date	Review days
K262397	Eizo Corporation	CuratOR EX2742	2026-09-11	59
K260884	Karl Storz SE & CO. KG	UNIDRIVE Select System	2026-09-01	168
K260972	Sony Corporation	OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor	2026-08-26	155
K261139	Freyja Healthcare, LLC	VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)	2026-08-13	128
K253541	Medical Impact	EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)	2026-07-24	252

Recalls for GCJ devices

274 product recalls in 94 recall events; 51 initiated in the last five years and 50 still open. Most recent: 2026-07-07.

Year	Recalls
2017	6
2018	7
2019	7
2020	2
2021	3
2022	7
2023	22
2024	15
2025	6
2026	1

Frequently asked questions

What is FDA product code GCJ?

GCJ is the FDA product code for laparoscope, general & plastic surgery. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General and Plastic Surgery panel.

What device class is GCJ?

Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).

How long does a 510(k) take for product code GCJ?

Across 1,430 cleared submissions the average was 115 days from receipt to decision (median 88).

Which companies have the most GCJ clearances?

KARL STORZ Endoscopy-America, Inc. (47); Origin Medsystems, Inc. (34); Phx Technologies Corp. (33); United States Surgical, A Division of Tyco Healthc (30); Richard Wolf Medical Instruments Corp. (28).

Have GCJ devices been recalled?

Yes: 274 product recalls across 94 recall events; the most recent began 2026-07-07.

Next steps

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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