FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COMFEEL PROTECTIVE RINGS
K Number: K832908
·
Decision Dec 12, 1983
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
4
Applicant Total
71
Review Days
105
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- COMFEEL PROTECTIVE RINGS
- K Number
- K832908
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4014
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Coloplast A/S
- Date Received
- August 29, 1983
- Decision Date
- December 12, 1983
- Product Code
- EYF
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EYF | Protector, Wound, Plastic | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EYF), ordered by most recent decision date.
IRRIVAGE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HARDING STERNAL SHIELD
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ANTI-FOG DISPOSABLE IV INDUCTION COVER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SI-PRO
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Coloplast A/S
| K Number | Device Name | ||
|---|---|---|---|
| K221874 | Altis Single Incision Sling System | Feb 15, 2023 | Substantially Equivalent |
| K220420 | Saffron Fixation System | Jun 10, 2022 | Substantially Equivalent |
| K191536 | Biatain Silicone Ag | Feb 21, 2020 | Substantially Equivalent |
| K181811 | ReTrace Ureteral Access Sheath | Sep 7, 2018 | Substantially Equivalent |
| K173527 | Digitex Delivery Device | Feb 12, 2018 | Substantially Equivalent |
| K140310 | Peristeen Anal Irrigation System | Sep 3, 2015 | Substantially Equivalent |
| K150935 | SpeediCath Compact Eve | Jul 2, 2015 | Substantially Equivalent |
| K150927 | Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff | May 27, 2015 | Substantially Equivalent |
| K143182 | Speedicath Compact Male | Jan 20, 2015 | Substantially Equivalent |
| K140523 | RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM | Jul 24, 2014 | Substantially Equivalent |