Shur-Grip
FDA 510(k) K912834 · Inman Medical Corp.
510(k) numberK912834
Submission
- Device name
- Shur-Grip
- Applicant
- Inman Medical Corp.
Arlington, TX, US - Received
- June 26, 1991
- Decision date
- July 26, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KDC – Instrument, Surgical, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code KDC
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|---|---|---|---|
| K943229 | Disposable Surgical Scissors and ForcepsKDC · Traditional | Y.M.K. International Co., Ltd. | 08/19/1994SE |
| K936226 | Surgimed Breast Localization Needle Wire SetKDC · Traditional | Meadox Medicals, Div. Boston Scientific Corp. | 03/07/1994SE |
| K920153 | Thermuff BagKDC · Traditional | Techstyles | 07/01/1992SE |
| K920263 | Manual Surgical InstrumentsKDC · Traditional | Phoenix Instruments Div. | 05/06/1992SE |
| K915064 | Disposable Cautery Abrasive PadKDC · Traditional | American Medical Mfg., Inc. | 03/11/1992SE |
| K914960 | Instrument OrganizerKDC · Traditional | O.R. Concepts, Inc. | 02/28/1992SE |
| K910079 | Disposable Introducer SheathKDC · Traditional | Applied Vascular Devices, Inc. | 02/27/1991SE |
| K905240 | VesseloopsKDC · Traditional | Sparta Surgical Corp. | 02/06/1991SE |
| K903649 | Bradley Tenaculum HolderKDC · Traditional | Marlo Surgical Technology | 11/02/1990SE |
| K900566 | Richard-Allan Vessel LoopsKDC · Traditional | Richard-Allan Medical Ind., Inc. | 05/03/1990SE |
More from Richard-Allan Medical Ind., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K933171 | Inman Irrigation Tapered ProbeKYZ · Traditional | 04/29/1994SE |
| K933169 | Inman Endoscopic Blunt DissectorGCJ · Traditional | 04/19/1994SE |
| K933094 | Insufflator Tubing Kit W/FilterHIF · Traditional | 04/18/1994SE |
| K933382 | Imc Cable/Wire CoverKKX · Traditional | 01/27/1994SE |
| K933774 | Imc Saline Wet DressingFRO · Traditional | 11/08/1993SN |
| K933306 | Imc 5.0MM Irrigation/Aspiration Probe W/HolesGCY · Traditional | 10/05/1993SE |
| K933305 | Imc 5.0MM Irrigation/Aspiration ProbeGCY · Traditional | 10/05/1993SE |
| K933170 | Inman Poole Tip Suction Probe W/Tubing KitGCY · Traditional | 09/16/1993SE |
| K932762 | 10.0MM Suction/Irrigation Probe & Tubing KitGCS · Traditional | 08/31/1993SE |
| K933371 | Imc Endoscopic Instrument HolderGCS · Traditional | 08/06/1993SE |
Questions and answers
When was Shur-Grip cleared by the FDA?
Shur-Grip (K912834) received a 510(k) decision of Substantially Equivalent on July 26, 1991, 30 days after the submission was received.
What is the product code of K912834?
The FDA product code is KDC – Instrument, Surgical, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.