Saphlift
FDA 510(k) K990062 · Genzyme Surgical Product (Genzyme Biosurgery)
510(k) numberK990062
Submission
- Device name
- Saphlift
- Applicant
- Genzyme Surgical Product (Genzyme Biosurgery)
North Attleboro, MA, US - Received
- January 8, 1999
- Decision date
- March 30, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MDM – Instrument, Manual, Surgical, General Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| K050575 | Futumeds No Patient Contact Safety Lancet with Pals SystemMDM · Traditional | Futumeds Sdn Bhd | 08/15/2005SE |
| K050957 | EutrocharMDM · Traditional | Special Devices, Inc. | 05/18/2005SE |
| K023173 | Andrews Introducer, Model ASI01MDM · Traditional | Andrews Surgical Innovations, Ltd. | 12/18/2002SE |
| K022059 | Microvasive Pulmonary GuidewireMDM · Traditional | Boston Scientific Corp | 11/13/2002SE |
| K013040 | Light Saber Introducer NeedleMDM · Traditional | Minrad, Inc. | 12/07/2001SE |
| K010184 | Chess Hand Surgery SystemMDM · Traditional | Canica Design, Inc. | 06/22/2001SE |
| K981579 | Endopouch Pro Specimen Retrieval BagMDM · Traditional | ETHICON, Inc. | 07/09/1998SE |
| K943968 | TunnelerMDM · Traditional | Denver Biomedicals, Inc. | 03/01/1995SE |
| K945430 | Dermavblade(Tm)MDM · Traditional | Hasting'S Biomedical Corp. | 11/28/1994SE |
More from Hasting'S Biomedical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K001440 | Nextstitch Cardiovascular Valve SutureGAT · Traditional | 11/13/2000SE |
| K001434 | 'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical SutureGAT · Traditional | 06/12/2000SN |
| K992088 | Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical SutureGAM · Traditional | 09/03/1999SE |
| K991416 | Endoscopic CameraGCJ · Traditional | 07/20/1999SE |
| K991191 | Bondek Polyglycolic Acid Synthetic Absorbable Surgical SutureGAM · Traditional | 06/22/1999SE |
| K982712 | Rapid Transfer Blood Bag Model A-1650, Rapid Transfer Blood Bag Model S-250CAC · Traditional | 12/18/1998SE |
| K980016 | Millennium Valve Introducer/Rotator HandleMOP · Traditional | 08/07/1998SE |
| K981322 | Cutalon Nylon Polyamide Surgical SutureGAR · Traditional | 07/07/1998SE |
Questions and answers
When was Saphlift cleared by the FDA?
Saphlift (K990062) received a 510(k) decision of Substantially Equivalent on March 30, 1999, 81 days after the submission was received.
What is the product code of K990062?
The FDA product code is MDM – Instrument, Manual, Surgical, General Use, a Class I (low risk) device regulated under 21 CFR 878.4800.