FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PEREGRINE 23GA CURVED LASER PROBE
K Number: K122905
·
Decision Apr 30, 2013
Classifications
1
FEI Numbers
26
Registration Numbers
27
Same Product Code
29
Applicant Total
19
Review Days
221
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Basic Information
- Device Name
- PEREGRINE 23GA CURVED LASER PROBE
- K Number
- K122905
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 886.4690
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Peregrine Surgical , Ltd.
- Date Received
- September 21, 2012
- Decision Date
- April 30, 2013
- Product Code
- HQB
- Advisory Committee
- Ophthalmic
- 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 |
|---|---|---|---|
| HQB | Photocoagulator And Accessories | FDA class 2 | Ophthalmic |
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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 |
| 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 |
| K980797 | PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR | May 19, 1998 | Substantially Equivalent |
| K980530 | PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.13 | May 12, 1998 | Substantially Equivalent |