SPIRIT RIDGE SILICONE CARVING BLOCK
FDA 510(k) clearance K961081 · decided 1996-05-22
Clearance details
- K-number
- K961081
- Device name
- SPIRIT RIDGE SILICONE CARVING BLOCK
- Applicant
- Rand Scientific Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-03-18
- Decision date
- 1996-05-22
- Days to decision
- 65 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
- Sacramento, CA, US
- Third-party review
- No
- Expedited review
- No
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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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TRANSAIRE(TM) RIGID GAS PERMEABLE CONTACT LENSES (P890044/S027) | Rand Scientific Corp. | 1994-01-26 |
| TRANSAIRE(TM) RIGID GAS PERMEABLE CONTACT LENSES (P890044/S026) | Rand Scientific Corp. | 1993-05-27 |
| TRANSAIRE(TM) RIGID GAS PERMEABLE CONTACT LENSES (P890044/S025) | Rand Scientific Corp. | 1993-02-09 |
| ADD RGP LENS FINISHING LABORATORIES. (P890044/S024) | Rand Scientific Corp. | 1993-02-05 |
| ADD RGP LENS FINISHING LABORATORIES. (P890044/S023) | Rand Scientific Corp. | 1992-09-30 |
| ADD RGP LENS FINISHING LABORATORIES. (P890044/S022) | Rand Scientific Corp. | 1992-09-01 |
| ADD RGP LENS FINISHING LABORATORIES. (P890044/S021) | Rand Scientific Corp. | 1992-06-26 |
| ADD RGP LENS FINISHING LABORATORIES. (P890044/S020) | Rand Scientific Corp. | 1992-04-14 |