Manual Surgical Instrments for Laparoscopy
FDA 510(k) K915372 · Unisurge, Inc.
510(k) numberK915372
Submission
- Device name
- Manual Surgical Instrments for Laparoscopy
- Applicant
- Unisurge, Inc.
Mountain View, CA, US - Received
- November 27, 1991
- Decision date
- April 6, 1992
- 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).
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| 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 |
|---|---|---|
| K943502 | UnigripGCJ · Traditional | 10/07/1994SE |
| K933720 | Instrument Actuating Device (Iad)GCJ · Traditional | 11/12/1993SE |
| K930605 | Applier, Surgical, ClipGCJ · Traditional | 10/08/1993SE |
| K930617 | Obgrip and Unitips(Tm)GCJ · Traditional | 08/11/1993SE |
| K932604 | Unigrip-Fh Surgical Handpiece/LaparoscopicGCJ · Traditional | 08/10/1993SE |
| K930809 | UnitipsGCJ · Traditional | 08/10/1993SE |
| K925917 | Unichannel(Tm Surgical GrasperGCJ · Traditional | 08/10/1993SE |
| K925882 | Unitips Surgical InstrumentsGCJ · Traditional | 08/10/1993SE |
| K926341 | Unitrocar(Tm) Reusable Surg Trocar/Resuse KitGCJ · Traditional | 05/17/1993SE |
| K926199 | Uniclip Surgical Clip ApplierGDO · Traditional | 04/20/1993SE |
Questions and answers
When was Manual Surgical Instrments for Laparoscopy cleared by the FDA?
Manual Surgical Instrments for Laparoscopy (K915372) received a 510(k) decision of Substantially Equivalent on April 6, 1992, 131 days after the submission was received.
What is the product code of K915372?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.