Reflex Esp with Finger Switches
FDA 510(k) K935105 · Richard-Allan Medical
510(k) numberK935105
Submission
- Device name
- Reflex Esp with Finger Switches
- Applicant
- Richard-Allan Medical
Richland, MI, US - Received
- October 22, 1993
- Decision date
- February 22, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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|---|---|---|
| K942207 | Reflex Ins Insufflation NeedleHIF · Traditional | 05/27/1994SE |
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| K933901 | Reflex(R) Ehs (Endoscopic Hernia Stapler)GAG · Traditional | 11/19/1993SE |
| K924881 | Reflex(R) EspGEI · Traditional | 07/23/1993SE |
| K924929 | Reflex(R) EcaHBT · Traditional | 07/21/1993SE |
| K905701 | Richard-Allan Sheet ClipKKX · Traditional | 02/19/1991SE |
| K905682 | Richard-Allan Clamp CoversFSM · Traditional | 02/19/1991SE |
Questions and answers
When was Reflex Esp with Finger Switches cleared by the FDA?
Reflex Esp with Finger Switches (K935105) received a 510(k) decision of Substantially Equivalent on February 22, 1994, 123 days after the submission was received.
What is the product code of K935105?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.