FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
H-H SUBGALEAL TROCAR
K Number: K865075
·
Decision Jan 13, 1987
Classifications
1
FEI Numbers
21
Registration Numbers
22
Same Product Code
12
Applicant Total
42
Review Days
15
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Basic Information
- Device Name
- H-H SUBGALEAL TROCAR
- K Number
- K865075
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.4545
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Holter-Hausner Intl.
- Date Received
- December 29, 1986
- Decision Date
- January 13, 1987
- Product Code
- GYK
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| GYK | Instrument, Shunt System Implantation | FDA class 1 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GYK), ordered by most recent decision date.
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V/P AND L/P CATHETER PASSERS
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PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER
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CORDIS TUNNELER
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HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE
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PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER
FDA 510(k)
FDA Class 1
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Other Clearances by Holter-Hausner Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K875287 | H-H FLUSHING RESERVOIR | Jul 14, 1988 | Substantially Equivalent |
| K874508 | H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG | Jan 19, 1988 | Substantially Equivalent |
| K872285 | H-H HUNTER ACTIVE TENDON IMPLANT DC | Sep 28, 1987 | Substantially Equivalent for Some Indications |
| K872284 | H-H HUNTER ACTIVE TENDON IMPLANT PC | Sep 28, 1987 | Substantially Equivalent for Some Indications |
| K872293 | H-H HUNTER ACTIVE TENDON IMPLANT BC | Sep 28, 1987 | Substantially Equivalent for Some Indications |
| K871351 | H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP | May 14, 1987 | Substantially Equivalent |
| K870660 | H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS | May 1, 1987 | Substantially Equivalent |
| K853436 | H-H HUNTER PASSIVE TENDON IMPLANT | Oct 16, 1985 | Substantially Equivalent |
| K853437 | H-H HUNTER TENDON ROD | Oct 16, 1985 | Substantially Equivalent |
| K853438 | H-H HUNTER ACTIVE TENDON IMPLANT | Sep 30, 1985 | Substantially Equivalent for Some Indications |