HYPAL ADHESIVE TAPE
FDA 510(k) clearance K832991 · decided 1984-01-30
Clearance details
- K-number
- K832991
- Device name
- HYPAL ADHESIVE TAPE
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-09-02
- Decision date
- 1984-01-30
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- KQX
- Device class
- 1
- Regulation number
- 888.1500
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Smith & Nephew
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 |
|---|---|---|
| ORTELIUS 800 (K011827) | Orthoscan , Ltd. | 2001-08-28 |
| INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE (K971079) | Interlogics, Inc. | 1997-07-09 |
| 3D-SPINE (K962377) | Skill Technologies, Inc. | 1996-09-03 |
| SPINAL TOUCH (K961212) | Fasstech | 1996-06-12 |
| INCLINOMETER (K954647) | J-Tech, Inc. | 1995-10-30 |
| DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS) (K943929) | Greenleaf Medical Systems, Inc. | 1995-05-15 |
| LARGE MUSCLE STRENGTH GAUGE (K945630) | J-Tech, Inc. | 1995-05-10 |
| SAUNDERS ELECTRONIC INCLINOMETER (K943898) | The Saunders Group | 1994-11-28 |
| INSIGHT ELECTRONIC ALIGNMENT INDICATOR (K940812) | Andronic Devices, Ltd. | 1994-11-21 |
| THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK (K925225) | Baltimore Therapeutic Equipment Co. | 1994-06-27 |
| ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA (K933063) | Isotechnologies, Inc. | 1994-01-27 |
| BOOST, MICE, GAMESYS. (K924416) | Penny and Giles Biometrics , Ltd. | 1993-06-15 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Ascension MCP (P000057/S013) | Smith & Nephew, Inc. | 2025-12-31 |
| ASCENSION MCP (P000057/S014) | Smith & Nephew, Inc. | 2025-08-05 |
| R3 Delta Ceramic Acetabular System (P150030/S049) | Smith & Nephew, Inc. | 2025-04-17 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030/S048) | Smith & Nephew, Inc. | 2025-03-03 |
| R3 Delta Ceramic Hip System (P150030/S045) | Smith & Nephew, Inc. | 2025-02-28 |
| R3 Delta Ceramic Acetabular System (P150030/S047) | Smith & Nephew, Inc. | 2025-02-21 |
| R3 Delta Ceramic Acetabular System (P150030/S046) | Smith & Nephew, Inc. | 2025-01-16 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S039) | Smith & Nephew, Inc. | 2025-01-10 |