KARL STORZ LARYNGOSCOPE ACCESSORIES
FDA 510(k) clearance K944295 · decided 1994-10-04
Clearance details
- K-number
- K944295
- Device name
- KARL STORZ LARYNGOSCOPE ACCESSORIES
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-08-29
- Decision date
- 1994-10-04
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- CAI
- Device class
- 1
- Regulation number
- 868.5240
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Culver City, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CONDENSATE COLLECTION KIT (K954480) | Nova-Ventrx | 1995-12-29 |
| UNICOR, INC. GAS SAMPLING LINES & CONNECTORS (K953788) | Unicor, Inc. | 1995-09-19 |
| UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT (K953787) | Unicor, Inc. | 1995-09-19 |
| PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (K952014) | Prima, Inc. | 1995-05-22 |
| PRIMA ADULT GAS SAMPLING CIRCUITS (K952019) | Prima, Inc. | 1995-05-22 |
| PRIMA COAXIAL CIRCUITS (K952018) | Prima, Inc. | 1995-05-22 |
| PRIMA PEDIATRIC GAS SAMPLING CIRCUITS (K952016) | Prima, Inc. | 1995-05-22 |
| PRIMA MAPLESON D CIRCUIT (K952017) | Prima, Inc. | 1995-05-22 |
| PRIMA PEDIATRIC ANESTHESIA CIRCUITS (K952020) | Prima, Inc. | 1995-05-22 |
| PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS (K952009) | Prima, Inc. | 1995-05-19 |
| SPIRO-FLEX (K945565) | Inhalation Plastics | 1995-01-13 |
| NEONATAL BREATHING CIRCUIT MODIFICATION (K932288) | Simplex Medical Systems, Inc. | 1994-12-30 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Photodynamic Diagnostic D-Light C System (P050027/S034) | KARL STORZ Endoscopy-America, Inc. | 2025-10-01 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S033) | KARL STORZ Endoscopy-America, Inc. | 2025-05-02 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S032) | KARL STORZ Endoscopy-America, Inc. | 2024-09-27 |
| KARL STORZ D-Light C PDD System (P050027/S031) | KARL STORZ Endoscopy-America, Inc. | 2023-05-05 |
| KARL STORZ D-Light C PDD System (P050027/S030) | KARL STORZ Endoscopy-America, Inc. | 2022-03-17 |
| KARL STORZ D-Light C PDD System (P050027/S028) | KARL STORZ Endoscopy-America, Inc. | 2022-02-04 |
| KARL STORZ D-Light C PDD System (P050027/S029) | KARL STORZ Endoscopy-America, Inc. | 2021-10-13 |
| D-Light C PDD System (P050027/S027) | KARL STORZ Endoscopy-America, Inc. | 2021-01-08 |