Product code FHA
- Device name
- Clamp, Penile
- Medical specialty
- Gastroenterology, Urology
- Device class
- 1
- Regulation number
- 876.5160
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974040 | C3 EXTERNAL MALE BLADDER CONTROL DEVICE | Timm Research Co. | 1998-07-14 |
| K971992 | UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) | Uromed Corp. | 1997-08-01 |
| K970308 | MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE | Mentor Urology, Inc. | 1997-04-02 |
| K964580 | CAP-AID (IMPROVED) | Nebel, Inc. | 1997-01-10 |
| K955810 | U-TEX | Laborie Medical Technologies, Ltd. | 1996-01-24 |
| K954959 | CAP-AID | Nebl, Inc. | 1995-12-06 |
| K952841 | THE ASSISTANT | Apple Medical Corp. | 1995-08-18 |
| K896160 | WILLIAMS PENILE ANESTHETIC RETAINER | Cook Urological, Inc. | 1990-02-16 |
| K885323 | DACOMED EXTERNAL MALE CONTINENCE DEVICE | Dacomed Corp. | 1989-02-08 |
| K863227 | COOK-VPI CONTINENCE CUFF | Cook Urological, Inc. | 1987-02-03 |
| K780137 | CLAMP, INCONTINENCE, BAUMRUCKER | Greenwald Surgical Co., Inc. | 1978-04-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00194613105082 | MSI Precision Specialty Instruments | Med Saver, Inc. | 2025-08-01 |
| 04049047064947 | Gimmi | Gimmi GmbH | 2025-05-20 |
| 00194613031305 | MSI Precision Specialty Instruments | Med Saver, Inc. | 2025-03-21 |
| 00194613103484 | MSI Precision Specialty Instruments | Med Saver, Inc. | 2025-03-21 |
| 00194613106959 | MSI Precision Specialty Instruments | Med Saver, Inc. | 2025-03-21 |
| 00194613111113 | MSI Precision Specialty Instruments | Med Saver, Inc. | 2025-03-21 |
| 00194613061531 | MSI Precision Specialty Instruments | Med Saver, Inc. | 2024-08-15 |
| 00887482075333 | Symmetry Surgical | ASPEN SURGICAL PRODUCTS, INC. | 2024-08-15 |
| 04049197264655 | RZ Medizintechnik GmbH | RZ-Medizintechnik GmbH | 2024-06-28 |
| 04049197264662 | RZ Medizintechnik GmbH | RZ-Medizintechnik GmbH | 2024-06-28 |
| 00840183523008 | BR Surgical, LLC | BR Surgical, LLC | 2024-06-10 |
| 00653599002179 | KindKlamp | ARGENTUM MEDICAL, LLC | 2024-02-07 |
| G586UR96208880 | Novo Surgical | NOVO SURGICAL, INC. | 2023-12-18 |
| 00842962125977 | HNM MEDICAL | HNM STAINLESS, LLC. | 2023-04-12 |
| B974ZC1100 | PENIS CLAMP | DR.FRIGZ INTERNATIONAL(PVT)LTD, | 2022-11-21 |
| 08800064400103 | Jeato 7 Incontinence Clamp | Jeato Med. CO., Ltd. | 2022-11-14 |
| 08800064400004 | Jeato Incontinence Clamp | Jeato Med. CO., Ltd. | 2022-11-14 |
| 00842331127403 | Novo Surgical Inc. | NOVO SURGICAL, INC. | 2022-11-09 |
| 00887482076194 | Symmetry Surgical® | ASPEN SURGICAL PRODUCTS, INC. | 2022-09-21 |
| 00887482076101 | Symmetry Vas | ASPEN SURGICAL PRODUCTS, INC. | 2022-09-21 |
| 00653599000861 | KindKlamp | ARGENTUM MEDICAL, LLC | 2020-01-22 |
| 00653599000007 | KindKlamp | ARGENTUM MEDICAL, LLC | 2020-01-22 |
| 10885403050091 | V. Mueller | CAREFUSION 2200, INC | 2018-08-30 |
| 10885403050275 | V. Mueller | STERIS CORPORATION | 2018-08-30 |
| 10885403050114 | V. Mueller | STERIS CORPORATION | 2018-08-30 |
| 10885403050107 | V. Mueller | STERIS CORPORATION | 2018-08-30 |
| 10381780396031 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-09-29 |
| 10801334000363 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-10-31 |
| 10801334000165 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-10-31 |
| 10801334000158 | Greenwald Surgical Company, Inc. | GRACE MANUFACTURING, INC. | 2016-10-31 |