The Assistant
FDA 510(k) K952841 · Apple Medical Corp.
510(k) numberK952841
Submission
- Device name
- The Assistant
- Applicant
- Apple Medical Corp.
Bolton, MA, US - Received
- June 21, 1995
- Decision date
- August 18, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FHA – Clamp, Penile
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5160
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FHA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974040 | C3 External Male Bladder Control DeviceFHA · Traditional | Timm Research Co. | 07/14/1998SE |
| K971992 | Uromed Alternative Bladder Control Continence DEVICE(ABCPN-0026)FHA · Traditional | Uromed Corp. | 08/01/1997SE |
| K970308 | Mentor Urology Triple Rib Occlusion Wrap for Male IncontinenceFHA · Traditional | Mentor Urology, Inc. | 04/02/1997SE |
| K964580 | Cap-Aid (Improved)FHA · Traditional | Nebel, Inc. | 01/10/1997SE |
| K955810 | U-TexFHA · Traditional | Laborie Medical Technologies, Ltd. | 01/24/1996SE |
| K954959 | Cap-AidFHA · Traditional | Nebl, Inc. | 12/06/1995SE |
| K896160 | Williams Penile Anesthetic RetainerFHA · Traditional | Cook Urological, Inc. | 02/16/1990SE |
| K885323 | Dacomed External Male Continence DeviceFHA · Traditional | Dacomed Corp. | 02/08/1989SE |
| K863227 | Cook-Vpi Continence CuffFHA · Traditional | Cook Urological, Inc. | 02/03/1987SE |
| K780137 | Clamp, Incontinence, BaumruckerFHA · Traditional | Greenwald Surgical Co., Inc. | 04/28/1978SE |
More from Greenwald Surgical Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K061651 | Fischer Cone Biopsy Excisor, Models 900-150, 151, 152, 154, 155, 157 and 158HGI · Traditional | 10/20/2006SE |
| K050256 | Apple Medical/Ob Mobius Elastic RetractorGAD · Traditional | 04/26/2005SE |
| K041131 | Apple Medical Ob Mobius Elastic RetractorGCJ · Traditional | 05/13/2004SE |
| K014005 | Apple Medical Mobius Elastic RetractorGCJ · Traditional | 02/15/2002SE |
| K000026 | Apple Medical One-Touch Uterine SamplerHHK · Traditional | 03/31/2000SE |
| K970788 | Pneumo-Matic Insufflation NeedleFHO · Traditional | 03/27/1997SE |
| K961460 | Lweet Cone Biopsy InstrumentHGI · Traditional | 11/19/1996SE |
| K941506 | Ureteral IlluminatorFCS · Traditional | 10/05/1994SE |
Questions and answers
When was The Assistant cleared by the FDA?
The Assistant (K952841) received a 510(k) decision of Substantially Equivalent on August 18, 1995, 58 days after the submission was received.
What is the product code of K952841?
The FDA product code is FHA – Clamp, Penile, a Class I (low risk) device regulated under 21 CFR 876.5160.