Mahe Instruments
FDA 510(k) K942821 · Mahe-Medizintechnik
510(k) numberK942821
Submission
- Device name
- Mahe Instruments
- Applicant
- Mahe-Medizintechnik
Nashville, TN, US - Received
- June 14, 1994
- Decision date
- November 2, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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More from Stryker Sustainability Solutions
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K933772 | Punch SurgicalLXH · Traditional | 02/01/1994SE |
| K925624 | Microsurgical InstrumentsGCJ · Traditional | 07/22/1993SE |
Questions and answers
When was Mahe Instruments cleared by the FDA?
Mahe Instruments (K942821) received a 510(k) decision of Substantially Equivalent on November 2, 1994, 141 days after the submission was received.
What is the product code of K942821?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.