SHUR-GRIP
FDA 510(k) clearance K912834 · decided 1991-07-26
Clearance details
- K-number
- K912834
- Device name
- SHUR-GRIP
- Applicant
- Inman Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-06-26
- Decision date
- 1991-07-26
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- KDC
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Arlington, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Inman Medical Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DISPOSABLE SURGICAL SCISSORS AND FORCEPS (K943229) | Y.M.K. International Co., Ltd. | 1994-08-19 |
| SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET (K936226) | Meadox Medicals, Div. Boston Scientific Corp. | 1994-03-07 |
| THERMUFF BAG (K920153) | Techstyles | 1992-07-01 |
| MANUAL SURGICAL INSTRUMENTS (K920263) | Phoenix Instruments Div. | 1992-05-06 |
| DISPOSABLE CAUTERY ABRASIVE PAD (K915064) | American Medical Mfg., Inc. | 1992-03-11 |
| INSTRUMENT ORGANIZER (K914960) | O.R. Concepts, Inc. | 1992-02-28 |
| DISPOSABLE INTRODUCER SHEATH (K910079) | Applied Vascular Devices, Inc. | 1991-02-27 |
| VESSELOOPS (K905240) | Sparta Surgical Corp. | 1991-02-06 |
| BRADLEY TENACULUM HOLDER (K903649) | Marlo Surgical Technology | 1990-11-02 |
| RICHARD-ALLAN VESSEL LOOPS (K900566) | Richard-Allan Medical Ind., Inc. | 1990-05-03 |
| KEY VASCULAR LOOPS (K896676) | Key Surgical, Inc. | 1990-02-27 |
| SPOON (K854894) | Euro-Med Intl. | 1986-05-02 |
Recalls involving this device
No recalls on record reference this clearance.