Punch Surgical
FDA 510(k) K933772 · Mahe-Medizintechnik
510(k) numberK933772
Submission
- Device name
- Punch Surgical
- Applicant
- Mahe-Medizintechnik
Nashville, TN, US - Received
- July 29, 1993
- Decision date
- February 1, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LXH – Orthopedic Manual Surgical Instrument
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
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|---|---|---|---|
| K192873 | SX-One MicroKnifeLXH · Traditional | Sonex Health, Inc. | 12/20/2019SE |
| K140414 | Imbibe NeedleLXH · Traditional | Orthovita, Inc. | 04/01/2014SE |
| K101609 | Self Retaining Soft Tissue RetractorLXH · Traditional | Koros USA, Inc. | 12/09/2010SE |
| K001507 | Microperforation InstrumentLXH · Traditional | Smith & Nephew, Inc. | 06/14/2000SE |
| K952495 | Anchors Away Soft Tissue Attachment SystemLXH · Traditional | Orthopedic Systems, Inc. | 01/22/1996SE |
| K943873 | Orthomet Anatomically Guided Carpal Tunnel Release SyLXH · Traditional | Orthomet, Inc. | 04/26/1995SE |
| K944188 | Spinal MarkerLXH · Traditional | Leibinger L.P. | 04/13/1995SE |
| K941896 | Steadman Ligament Graft Passer and ProtectorLXH · Traditional | Depuy, Inc. | 11/07/1994SE |
| K941711 | Hyperflex Flexible GuidewiresLXH · Traditional | Linvatec Corp. | 08/26/1994SE |
| K941605 | Stryker Femoral Canal Brush, Acetabular BrushLXH · Traditional | Stryker Corp. | 08/05/1994SE |
More from Stryker Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K942821 | Mahe InstrumentsGEI · Traditional | 11/02/1994SE |
| K942819 | Trocar with ShieldGCJ · Traditional | 08/23/1994SE |
| K933768 | Coagulator, Laparoscopic, Lunipolar/AccessoriesHET · Traditional | 06/27/1994SE |
| K933767 | Forceps, Biopsy Gynecological Instru/BiopsyHFB · Traditional | 05/26/1994SE |
| K933770 | Forceps, ENT Instr, ENT Manual Surg Retract/All TypeLRC · Traditional | 03/23/1994SE |
| K935442 | Mahe InstrumentsGCJ · Traditional | 03/14/1994SE |
| K925624 | Microsurgical InstrumentsGCJ · Traditional | 07/22/1993SE |
Questions and answers
When was Punch Surgical cleared by the FDA?
Punch Surgical (K933772) received a 510(k) decision of Substantially Equivalent on February 1, 1994, 187 days after the submission was received.
What is the product code of K933772?
The FDA product code is LXH – Orthopedic Manual Surgical Instrument, a Class I (low risk) device regulated under 21 CFR 888.4540.