HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM
FDA 510(k) clearance K990086 · decided 1999-03-31
Clearance details
- K-number
- K990086
- Device name
- HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM
- Applicant
- Integra Lifesciences Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-01-11
- Decision date
- 1999-03-31
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- KGN
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Plainsboro, NJ, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
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| MatriDerm (K261224) | Medskin Solutions Dr. Suwelack AG | 2026-05-14 |
| Derma-Gide (K260532) | Geistlich Pharma AG | 2026-03-19 |
| LacertaMatrix (K260218) | Lacerta Life Sciences | 2026-02-19 |
| CollOvine™ Wound Powder (K253140) | Ovigenex, LLC | 2026-02-10 |
| Device 104 Particulate (K251323) | Geistlich Pharma AG | 2026-01-22 |
| Theracor (K253339) | Stimlabs, LLC | 2025-12-22 |
Recalls involving this device
No recalls on record reference this clearance.