Forceps, ENT Instr, ENT Manual Surg Retract/All Type
FDA 510(k) K933770 · Mahe-Medizintechnik
510(k) numberK933770
Submission
- Device name
- Forceps, ENT Instr, ENT Manual Surg Retract/All Type
- Applicant
- Mahe-Medizintechnik
Nashville, TN, US - Received
- July 29, 1993
- Decision date
- March 23, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LRC – Instrument, Ent Manual Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Specialty
- Ear, Nose, Throat
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More from Acclarent, Inc.
| 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 |
| 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 Forceps, ENT Instr, ENT Manual Surg Retract/All Type cleared by the FDA?
Forceps, ENT Instr, ENT Manual Surg Retract/All Type (K933770) received a 510(k) decision of Substantially Equivalent on March 23, 1994, 237 days after the submission was received.
What is the product code of K933770?
The FDA product code is LRC – Instrument, Ent Manual Surgical, a Class I (low risk) device regulated under 21 CFR 874.4420.