FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SOFT PLUG Extended Duration 180 Tapered Canalicular Plug
K Number: K213988
·
Decision Jun 3, 2022
Classifications
1
FEI Numbers
37
Registration Numbers
38
Same Product Code
48
Applicant Total
17
Review Days
165
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Basic Information
- Device Name
- SOFT PLUG Extended Duration 180 Tapered Canalicular Plug
- K Number
- K213988
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oasis Medical, Inc.
- Date Received
- December 20, 2021
- Decision Date
- June 3, 2022
- Product Code
- LZU
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LZU | Plug, Punctum | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LZU), ordered by most recent decision date.
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Other Clearances by Oasis Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K162361 | Soft Plug Extended Duration 180 Canalicular Plug | Apr 17, 2017 | Substantially Equivalent |
| K032297 | DISPOSABLE N-PE MICKROKERATOME BLADES | Aug 26, 2003 | Substantially Equivalent |
| K030401 | DISPOSABLE M2-PE MICROKERATOME BLADES | Jun 19, 2003 | Substantially Equivalent |
| K022205 | DISPOSABLE N-PE MICROKERATOME BLADES | Oct 3, 2002 | Substantially Equivalent |
| K013613 | SOFT PLUG ABSORBABLE PLUG-SA | Jun 27, 2002 | Substantially Equivalent |
| K003820 | DISPOSABLE CB-PE MICROKERATOME BLADES | Mar 8, 2001 | Substantially Equivalent |
| K001176 | DISPOSABLE MICROKERATOME BLADES-PE | Sep 21, 2000 | Substantially Equivalent |
| K980437 | SILICONE PUNCTAL PLUG | Apr 30, 1998 | Substantially Equivalent |
| K950798 | POSTERIOR CAPSULE SHIELD | May 22, 1995 | Substantially Equivalent |
| K950241 | OPHTHALMIC SPONGES | Feb 27, 1995 | Substantially Equivalent |