FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR
K Number: K980797
·
Decision May 19, 1998
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
39
Applicant Total
19
Review Days
78
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Basic Information
- Device Name
- PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR
- K Number
- K980797
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Peregrine Surgical , Ltd.
- Date Received
- March 2, 1998
- Decision Date
- May 19, 1998
- Product Code
- MPA
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| MPA | Endoilluminator | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MPA), ordered by most recent decision date.
Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);
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FDA Class 2
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Other Clearances by Peregrine Surgical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K151604 | 23ga Chandelier Illuminator, 25ga Chandelier Illuminator | Sep 11, 2015 | Substantially Equivalent |
| K132614 | PEREGRINE CURVED ILLUMINATING LASER PROBE | Nov 14, 2013 | Substantially Equivalent |
| K122997 | 23GA CURVED ILLUMINATING LASER PROBE | Jun 26, 2013 | Substantially Equivalent |
| K122905 | PEREGRINE 23GA CURVED LASER PROBE | Apr 30, 2013 | Substantially Equivalent |
| K061024 | PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60 | Jun 21, 2006 | Substantially Equivalent |
| K031023 | PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10 | Jun 27, 2003 | Substantially Equivalent |
| K024061 | PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00 | Mar 7, 2003 | Substantially Equivalent |
| K990518 | PEREGRINE WET SET, MODEL PD400.00 | Mar 25, 1999 | Substantially Equivalent |
| K981907 | V.F.I.-VISCOUS FLUID INFUSION TUBING SET | Aug 4, 1998 | Substantially Equivalent |
| K980530 | PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.13 | May 12, 1998 | Substantially Equivalent |