SILICONE ELASTOMER SHEETING
FDA 510(k) clearance K974653 · decided 1998-03-13
Clearance details
- K-number
- K974653
- Device name
- SILICONE ELASTOMER SHEETING
- Applicant
- Specialty Surgical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-12-15
- Decision date
- 1998-03-13
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- MIB
- Device class
- 2
- Regulation number
- 874.3620
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Hamilton, MT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Specialty Surgical Products
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 |
|---|---|---|
| MISTI Silicone Implant (K241150) | Keosan Trading Co. | 2024-07-24 |
| Pre-Formed Silicone Block (K223051) | International Medical Devices, Inc. | 2023-02-03 |
| ShiNeo Silicone Implant (K222748) | Shineo Technology Co., Ltd. | 2022-12-23 |
| AugMENTA Penile Implant (K200073) | Augmenta, LLC | 2022-09-30 |
| Pre-Formed Penile Silicone Block (K220760) | International Medical Devices, Inc. | 2022-05-13 |
| BioSiCar Silicone Implant (K193392) | Metalware Technology Corp. | 2020-07-20 |
| Pre-Formed Penile Silicone Block (K181387) | International Medical Devices, Inc. | 2019-01-23 |
| SOFTXIL (K171851) | Bistool | 2018-03-16 |
| Pre-Formed Penile Silicone Block (K162624) | International Medical Devices, Inc. | 2017-02-01 |
| CALF IMPLANT, MODEL EC17-X (K052505) | Implantech Associates, Inc. | 2005-11-04 |
| GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X (K052504) | Implantech Associates, Inc. | 2005-11-04 |
| SILIMED PECTORAL IMPLANT (K042054) | Silimed, Inc. | 2005-02-23 |
Recalls involving this device
No recalls on record reference this clearance.