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

Laparoscope, General & Plastic Surgery

21 CFR 876.1500 / Gastroenterology, Urology
FDA source (opens on fda.gov)

GCJ is the FDA product code for Laparoscope, General & Plastic Surgery, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "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)". As of , FDA records hold 1,428 510(k) clearances under this code, the most recent dated , and 274 recalls.

Classification record

Product code
GCJ
Device name
Laparoscope, General & Plastic Surgery
FDA 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).
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1,430
Ingested recalls
274

Clearances, product code GCJ

By decision year
1,430 clearances under product code GCJ with a decision year between 1977 and 2026, 1994 the highest year at 217.
Show the numbers
510(k) clearances under FDA product code GCJ by decision year
YearClearances
19773
19833
19861
19891
199161
199244
1993184
1994217
1995142
199642
199745
199852
199943
200024
200130
200230
200327
200416
200514
200622
200718
200819
200921
201024
201115
201217
201315
201419
201526
201627
201720
201821
201915
202028
202118
202220
202331
202429
202521
202625

Applicants with the most clearances

Product code GCJ
Applicants holding the most 510(k) clearances under product code GCJ
ApplicantClearances
Karl Storz Endoscopy-America, Inc.57
Stryker Corp.46
Origin Medsystems, Inc.34
Phx Technologies Corp.33
Ethicon Endo-Surgery Inc31
United States Surgical, A Division of Tyco Healthc30
Richard Wolf Medical Instruments Corp.28
Applied Medical Resources Corp26
Computer Motion, Inc.21
The Tulip Mfg. Co.19

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 489 companies shown, in name order