Access Surgical Monopolar Endoscopic Surg. Instrum
FDA 510(k) K922425 · Access Surgical Intl., Inc.
510(k) numberK922425
Submission
- Device name
- Access Surgical Monopolar Endoscopic Surg. Instrum
- Applicant
- Access Surgical Intl., Inc.
Bedminster, NJ, US - Received
- May 21, 1992
- Decision date
- November 17, 1992
- 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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| K954536 | Blade, Scalpel & Blade, HandelOCZ · Traditional | 11/29/1995SE |
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| K945545 | Access Surgical Int'L Thoracic Endoscopic Surgical InstrumentsGCJ · Traditional | 01/12/1995SE |
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| K940587 | Flex-I-PortGCJ · Traditional | 03/29/1994SE |
| K933192 | Access Surgical Int'L Inc. Endoscopic Surg. Inst.GCJ · Traditional | 11/18/1993SE |
| K922424 | Access Surgical Int'L Endoscopic Surgical Instrum.GCJ · Traditional | 11/25/1992SE |
| K922423 | Access Surgical Bipolar Endoscopic Surg. Instrum.GEI · Traditional | 11/18/1992SE |
Questions and answers
When was Access Surgical Monopolar Endoscopic Surg. Instrum cleared by the FDA?
Access Surgical Monopolar Endoscopic Surg. Instrum (K922425) received a 510(k) decision of Substantially Equivalent on November 17, 1992, 180 days after the submission was received.
What is the product code of K922425?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.