FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URESIL LAPAROSCOPIC RETRACTOR
K Number: K921417
·
Decision Oct 8, 1993
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
337
Applicant Total
45
Review Days
563
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Basic Information
- Device Name
- URESIL LAPAROSCOPIC RETRACTOR
- K Number
- K921417
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Uresil Corp.
- Date Received
- March 24, 1992
- Decision Date
- October 8, 1993
- Product Code
- HET
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Uresil Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K003753 | GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE | Jan 4, 2001 | Substantially Equivalent |
| K980278 | URESIL VASCU-FLO INFUSION CATHETER | Nov 20, 1998 | Substantially Equivalent |
| K981344 | URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING | Sep 10, 1998 | Substantially Equivalent |
| K980282 | URESIL DILATOR WITH RADIOPAQUE MARKER | Apr 24, 1998 | Substantially Equivalent |
| K980889 | URESIL NEPHRO-URETERAL STENT | Apr 8, 1998 | Substantially Equivalent |
| K972582 | URESIL GUIDEWIRE | Nov 21, 1997 | Substantially Equivalent |
| K972583 | URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S | Aug 29, 1997 | Substantially Equivalent |
| K953923 | URESIL INTRODUCING NEEDLE | Sep 8, 1995 | Substantially Equivalent |
| K945934 | URESIL(R) GUIDEWIRE | Jul 10, 1995 | Substantially Equivalent |
| K942688 | NEPHRO-URETERAL STENT | Jun 6, 1995 | Substantially Equivalent |