Jarit Surgical Instruments
FDA 510(k) K931928 · J. Jamner Surgical Instruments, Inc.
510(k) numberK931928
Submission
- Device name
- Jarit Surgical Instruments
- Applicant
- J. Jamner Surgical Instruments, Inc.
Great Neck, NY, US - Received
- April 16, 1993
- Decision date
- November 10, 1993
- 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 |
|---|---|---|
| K082349 | Jarit Hulka Uterine Tenaculum ForcepsHDC · Traditional | 11/21/2008SE |
| K944670 | Jarit Recommended Sinus InstrumentsEOB · Traditional | 02/02/1995SE |
| K944870 | Jarit Endoscopes, Models 600-600; 600-630; 600-650; and 600-680GCJ · Traditional | 11/02/1994SE |
| K941565 | Jarit Recommended Sinus InstrumentsEOB · Traditional | 05/16/1994SE |
| K932456 | Jarit Surgical InstrumentsKNF · Traditional | 04/21/1994SE |
| K933728 | Jarit Surgical Instruments: Catalog 615-330, 615-331, 615-334, 615-335, 615-338, 615-339GEI · Traditional | 02/23/1994SE |
| K931959 | Jarit Surgical InstrumentsGEI · Traditional | 10/05/1993SE |
| K931878 | Jarit Endoscopes, 600-600; 600-630; 600-650; 680GCJ · Traditional | 08/19/1993SE |
| K771625 | Leiningeo Aortic Punch #310-395 & 397DWS · Traditional | 09/12/1977SE |
| K771624 | Cope Lung Forceps #305-218GEN · Traditional | 09/06/1977SE |
Questions and answers
When was Jarit Surgical Instruments cleared by the FDA?
Jarit Surgical Instruments (K931928) received a 510(k) decision of Substantially Equivalent on November 10, 1993, 208 days after the submission was received.
What is the product code of K931928?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.