FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER
K Number: K870773
·
Decision Jul 10, 1987
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
23
Review Days
134
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Basic Information
- Device Name
- ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER
- K Number
- K870773
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Hgm, Inc.
- Date Received
- February 26, 1987
- Decision Date
- July 10, 1987
- Product Code
- LLF
- Advisory Committee
- Unknown
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| LLF | Laser, Neurosurgical, Argon | FDA class 3 | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LLF), ordered by most recent decision date.
CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE
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·Unknown
MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION
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FDA Class 3
·Unknown
COOPER MEDICAL MODEL 770
FDA 510(k)
FDA Class 3
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Other Clearances by Hgm, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K950120 | SMART PLUG | Aug 11, 1995 | Substantially Equivalent |
| K931072 | HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE | Nov 10, 1994 | Substantially Equivalent |
| K931784 | HGM ILLUMINATING IMAGING ENDOCULAR PROBE | Mar 1, 1994 | Substantially Equivalent |
| K933333 | HGM SCANMAN PLUS | Sep 23, 1993 | Substantially Equivalent |
| K931499 | Q-11 OPHTHALMIC LASER | Aug 19, 1993 | Substantially Equivalent |
| K925663 | HGM ASPIRATING ENDOOCULAR(TM) PROBE | Aug 17, 1993 | Substantially Equivalent |
| K930543 | E-25 KRYPTON ION LASER (SURGICA K5) | Jun 22, 1993 | Substantially Equivalent |
| K880908 | MODEL PC ARGON LASER | May 3, 1988 | Substantially Equivalent |
| K873773 | ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER | Oct 13, 1987 | Substantially Equivalent |
| K872630 | ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO. | Aug 25, 1987 | Substantially Equivalent |