Raylor(Tm) Dissecting Hook
FDA 510(k) K864425 · Cedar Surgical, Inc.
510(k) numberK864425
Submission
- Device name
- Raylor(Tm) Dissecting Hook
- Applicant
- Cedar Surgical, Inc.
Minnetonka, MN, US - Received
- November 10, 1986
- Decision date
- December 12, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GDG – Hook, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GDG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K900069 | Modified PGL Absorbable Staple*GDG · Traditional | United States Surgical, A Division of Tyco Healthc | 04/16/1990SE |
| K891898 | Skin Hooks, Various TypesGDG · Traditional | Zinnanti Surgical Instruments, Inc. | 04/12/1989SE |
| K843136 | Brimfield Cannulated Grasping HooksGDG · Traditional | Brimfield Scientific Instruments | 09/25/1984SE |
| K841010 | Surgical Hooks, VariousGDG · Traditional | Premier Dental Products Co. | 05/01/1984SE |
| K812562 | Surgical Retractor & Elastic Stays, DispGDG · Traditional | Humboldt Products | 10/02/1981SE |
| K791120 | Middle Ear Picks, Hooks Curettes,GDG · Traditional | Xomed, Inc. | 07/10/1979SE |
| K780289 | Nerve ApproximaterGDG · Traditional | Edward Weck, Inc. | 06/14/1978SE |
| K771190 | Abramson Trachea Hook & RetractorGDG · Traditional | Edward Weck, Inc. | 07/11/1977SE |
| K771187 | Dermahook #382-805GDG · Traditional | Edward Weck, Inc. | 07/11/1977SE |
More from Edward Weck, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K873692 | Raylor(Tm) Drill StopHBE · Traditional | 12/17/1987SE |
| K872281 | Raylor Fusion FunnelHXR · Traditional | 11/02/1987SE |
| K873690 | Cedar(Tm) Pelvic CushionLWG · Traditional | 10/26/1987SE |
| K873691 | Cedar(Tm) Retractor RingGZT · Traditional | 09/28/1987SE |
| K864426 | Raylor(Tm) Depth GaugeHTJ · Traditional | 11/26/1986SE |
| K864424 | Raylor(Tm) Protective RetractorGAD · Traditional | 11/26/1986SE |
| K864421 | Raylor(Tm) Periosteal ElevatorsGEG · Traditional | 11/26/1986SE |
| K864423 | Raylor(Tm) Osteotomes · Traditional | 11/24/1986SE |
| K864422 | Raylor(Tm) MalletHWA · Traditional | 11/24/1986SE |
| K863416 | Raylor Mini-ProbeHAO · Traditional | 09/24/1986SE |
Questions and answers
When was Raylor(Tm) Dissecting Hook cleared by the FDA?
Raylor(Tm) Dissecting Hook (K864425) received a 510(k) decision of Substantially Equivalent on December 12, 1986, 32 days after the submission was received.
What is the product code of K864425?
The FDA product code is GDG – Hook, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.