FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
53-100 TO 53-120 VARIOUS RECTAL SPECULA(SIMS, MATH
K Number: K851797
·
Decision May 23, 1985
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
0
Applicant Total
79
Review Days
28
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Basic Information
- Device Name
- 53-100 TO 53-120 VARIOUS RECTAL SPECULA(SIMS, MATH
- K Number
- K851797
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.4730
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Artiberia
- Date Received
- April 25, 1985
- Decision Date
- May 23, 1985
- Product Code
- FFQ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FFQ | Speculum, Rectal | FDA class 1 | Gastroenterology, Urology |
Other Clearances by Artiberia
| K Number | Device Name | ||
|---|---|---|---|
| K851745 | 1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B | Aug 29, 1985 | Substantially Equivalent |
| K851786 | 27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF | Jul 9, 1985 | Substantially Equivalent |
| K851723 | 1300/10 TO 1305/89-92 VARIOUS CUTTING INSTRUMENTS | Jul 2, 1985 | Substantially Equivalent |
| K851727 | 2020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CA | Jul 2, 1985 | Substantially Equivalent |
| K851722 | 1285/5 TO 1295 VARIOUS TYPES OF DENTAL EXCAVATORS | Jul 2, 1985 | Substantially Equivalent |
| K851720 | 1155/1 TO 1162/12 VARIOUS TYPES GUM SCISSORS | Jul 2, 1985 | Substantially Equivalent |
| K851721 | 1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS | Jul 2, 1985 | Substantially Equivalent |
| K851718 | 930/0 TO 950/6 VARIOUS TYPES OF BONE CURETTES | Jul 2, 1985 | Substantially Equivalent |
| K851719 | 1070/15 TO 1078/17 VARIOUS TYPES NEEDLE HOLDERS | Jul 2, 1985 | Substantially Equivalent |
| K851724 | 1410/1 TO 1435/13 VARIOUS PROBES & EXPLORERS | Jul 2, 1985 | Substantially Equivalent |