Birtcher Laparoscope and Accessories
FDA 510(k) K932987 · Birtcher Medical Systems, Inc.
510(k) numberK932987
Submission
- Device name
- Birtcher Laparoscope and Accessories
- Applicant
- Birtcher Medical Systems, Inc.
Irvine, CA, US - Received
- June 18, 1993
- Decision date
- April 25, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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).
Other 510(k)s with product code GCJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262397 | CuratOR EX2742GCJ · Traditional | Eizo Corporation | 09/11/2026SE |
| K260884 | UNIDRIVE Select SystemGCJ · Traditional | Karl Storz SE & CO. KG | 09/01/2026SE |
| K260972 | OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorGCJ · Traditional | Sony Corporation | 08/26/2026SE |
| K261139 | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)GCJ · Traditional | Freyja Healthcare, LLC | 08/13/2026SE |
| K253541 | EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ…GCJ · Traditional | Medical Impact | 07/24/2026SE |
| K261614 | LED LCD Monitor (OEV-271H)GCJ · Traditional | Lg Electronics.Inc | 07/17/2026SE |
| K261249 | Universal Seal (5-12 mm)GCJ · Traditional | Intuitive Surgical, Inc. | 07/14/2026SE |
| K260710 | FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm…GCJ · Traditional | FloShield, Inc. | 06/11/2026SE |
| K260414 | Tech-Image Video Endoscope SystemGCJ · Traditional | Tech-Image CO., LTD. | 06/10/2026SE |
| K253994 | TroKit Laparoscope Lens WiperGCJ · Traditional | TroCare, LLC | 06/04/2026SE |
More from TroCare, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K932779 | Birtcher Swivel Grip Laparoscopic Probes & Access.HET · Traditional | 03/21/1995SE |
| K944681 | Lectrosurigical, Cutting and Coagulation and AccessoriesGEI · Traditional | 12/22/1994SE |
| K936114 | Birtcher Pericardial KnivesGCJ · Traditional | 04/25/1994SE |
| K931771 | Birtcher Endoscopic CorkscrewHET · Traditional | 04/25/1994SE |
| K931654 | Birtcher Magnetic Retriever (GS-3100)HET · Traditional | 04/25/1994SE |
| K930887 | Birtcher Bronchus & Lung Clamp (GS-1620 & GS-1600)GCJ · Traditional | 04/25/1994SE |
| K933319 | Birtcher GS-9480 Integrated 3-CHIP Camera/Xenon Light Source Visualization SystemGCY · Traditional | 10/27/1993SE |
| K930302 | Birtcher Sure Clean Instrument SystemGCI · Traditional | 10/27/1993SE |
| K930496 | GI-1090,1095,1080,1085,1086,1088, Endo. ClampsGCI · Traditional | 04/20/1993SE |
| K925824 | Solos Fan RetractorsGCJ · Traditional | 03/01/1993SE |
Questions and answers
When was Birtcher Laparoscope and Accessories cleared by the FDA?
Birtcher Laparoscope and Accessories (K932987) received a 510(k) decision of Substantially Equivalent on April 25, 1994, 311 days after the submission was received.
What is the product code of K932987?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.