Ispvac TM
FDA 510(k) K802973 · Innovative Surgical Products, Inc.
510(k) numberK802973
Submission
- Device name
- Ispvac TM
- Applicant
- Innovative Surgical Products, Inc.
Mchenry, IL, US - Received
- November 18, 1980
- Decision date
- December 19, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GCY – Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4680
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GCY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972703 | Redyrob-Closed Wound Drainage SystemGCY · Traditional | B.Braun Medical, Inc. | 10/01/1997SE |
| K971036 | Odontit Autogenous Bone Collection DeviceGCY · Traditional | Interpore Intl. | 06/03/1997SE |
| K963839 | Cordis Suction Reservoir - Model Number: 910-500GCY · Traditional | Cordis Corp. | 12/12/1996SE |
| K960099 | Penrose Drain Models 6001 - 6007GCY · Traditional | Sil-Med Corp. | 03/11/1996SE |
| K950754 | Macro Suction Tube Model No 10061GCY · Traditional | Dlp, Inc. | 04/25/1995SE |
| K936223 | Pressure Irrigating SystemGCY · Traditional | Level 1 Technologies, Inc. | 05/12/1994SE |
| K930615 | Autovac Closed Wound Suction SystemGCY · Traditional | Boehringer Laboratories | 02/22/1994SE |
| K933319 | Birtcher GS-9480 Integrated 3-CHIP Camera/Xenon Light Source Visualization SystemGCY · Traditional | Birtcher Medical Systems, Inc. | 10/27/1993SE |
| K933306 | Imc 5.0MM Irrigation/Aspiration Probe W/HolesGCY · Traditional | Inman Medical Corp. | 10/05/1993SE |
| K933305 | Imc 5.0MM Irrigation/Aspiration ProbeGCY · Traditional | Inman Medical Corp. | 10/05/1993SE |
More from Inman Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K843041 | Heslin Dispos. Tubing SetHQE · Traditional | 11/21/1984SE |
| K840695 | Phacoemulsification KitsHQC · Traditional | 05/22/1984SE |
| K840693 | Disposable Scleral Globe PlugLXP · Traditional | 05/22/1984SE |
| K840694 | Lens Insertion GlideKYB · Traditional | 05/09/1984SE |
| K841072 | Irrigation, Aspiration Tubing SetsHQC · Traditional | 03/29/1984SE |
| K832235 | Disposable Vitrectomy HandpieceHQE · Traditional | 09/29/1983SE |
| K821496 | Disposable Irriga/Aspir. SystemKDH · Traditional | 06/22/1982SE |
| K820765 | Pleural Drainage ReservoirGCX · Traditional | 04/15/1982SE |
| K820680 | Disposable Tubing SetsKYG · Traditional | 04/09/1982SE |
| K801350 | Acuvac(Tm) Suction Reservoir 400CC andGCY · Traditional | 07/14/1980SE |
Questions and answers
When was Ispvac TM cleared by the FDA?
Ispvac TM (K802973) received a 510(k) decision of Substantially Equivalent on December 19, 1980, 31 days after the submission was received.
What is the product code of K802973?
The FDA product code is GCY – Apparatus, Suction, Single Patient Use, Portable, Nonpowered, a Class I (low risk) device regulated under 21 CFR 878.4680.