Jarit Surgical Instruments
FDA 510(k) K931959 · J. Jamner Surgical Instruments, Inc.
510(k) numberK931959
Submission
- Device name
- Jarit Surgical Instruments
- Applicant
- J. Jamner Surgical Instruments, Inc.
Great Neck, NY, US - Received
- April 21, 1993
- Decision date
- October 5, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
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 GEI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254185 | Potenza PrimeGEI · Traditional | Jeisys Medical Incorporated | 09/11/2026SE |
| K262364 | Ellian Enigma RF DeviceGEI · Traditional | Ellian Corp | 09/02/2026SE |
| K253859 | Scarlet Pro (Scarlet Pro)GEI · Traditional | VIOL Co., Ltd. | 08/27/2026SE |
| K252535 | Inno-Switch Laparoscopic InstrumentsGEI · Traditional | Taiwan Surgical Corporation | 08/25/2026SE |
| K261179 | AlphaTriPart - Monopolar MIC InstrumentsGEI · Traditional | Gimmi GmbH | 07/22/2026SE |
| K253504 | VolnewmerGEI · Traditional | Classys, Inc. | 07/13/2026SE |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…GEI · Traditional | Olympus Medical Systems Corp. | 07/01/2026SE |
| K253484 | Lutronic GeniusGEI · Traditional | Cynosure Lutronic Technology Corporation | 06/29/2026SE |
| K251492 | Irrigation Tubing Bipolar Cord SetGEI · Traditional | New Deantronics Taiwan , Ltd. | 06/29/2026SE |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingGEI · Traditional | Stryker Sustainability Solutions | 06/18/2026SE |
More from Stryker Sustainability Solutions
| 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 |
| K931928 | Jarit Surgical InstrumentsGCJ · Traditional | 11/10/1993SE |
| 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 (K931959) received a 510(k) decision of Substantially Equivalent on October 5, 1993, 167 days after the submission was received.
What is the product code of K931959?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.