Atlas FDA

SOLITAIRE

FDA 510(k) clearance K972101 · decided 1997-09-29

Clearance details

K-number
K972101
Device name
SOLITAIRE
Applicant
Heraeus Kulzer, Inc.
Decision
Substantially Equivalent
Date received
1997-06-04
Decision date
1997-09-29
Days to decision
117 days
Clearance type
Traditional
Product code
KLE
Device class
2
Regulation number
872.3200
Medical specialty
Dental
Advisory committee
Dental
Location
South Bend, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Bard Access Systems, Inc., Gauderer Genie* II PEG (Percutaneous Endoscopic Gastrostomy) Sa recall (Z-2179-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Gauderer Genie* II PEG (Percutaneous Endoscopic Gastrostomy) Sa recall (Z-2180-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System recall (Z-2181-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System recall (Z-2182-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Bard* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - recall (Z-2183-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., FASTRAC "Pull" Gastric Access Port Kit, REF 005729, 20F, Steril recall (Z-2184-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., FASTRAC* "Pull" Gastric Access Port Safety System, REF 006033, recall (Z-2185-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., FASTRAC* Guidewire Gastric Access Port Safety System, REF 00603 recall (Z-2186-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System recall (Z-2187-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Safety System, REF 007023, recall (Z-2188-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Fastrac* Guidewire Gastric Access Port Safety System, REF 00702 recall (Z-2189-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Fastrac* Guidewire Gastric Access Port Safety System, REF 00703 recall (Z-2190-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Fastrac* Guidewire Gastric Access Port Safety System, REF 00703 recall (Z-2191-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007036, 24F, Steri recall (Z-2192-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007037, 16F, Steri recall (Z-2193-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007038, 14F, Steri recall (Z-2194-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007050, 24F, Steri recall (Z-2195-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Safety System, REF 007052, recall (Z-2196-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Safety System, REF 007056, recall (Z-2197-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Fastrac* "Pull" Gastric Access Port Kit, REF 007078, 20F, Steri recall (Z-2198-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Fastrac* Guidewire Gastric Access Port Kit, REF 007082, 20F, St recall (Z-2199-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Ponsky* Deluxe "Pull" PEG (Percutaneous Endoscopic Gastrostomy) recall (Z-2200-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Bard* Deluxe Guidewire PEG (Percutaneous Endoscopic Gastrostomy recall (Z-2201-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Ponsky* Deluxe "Pull" PEG (Percutaneous Endoscopic Gastrostomy) recall (Z-2202-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Bard* Deluxe Guidewire PEG (Percutaneous Endoscopic Gastrostomy recall (Z-2203-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System recall (Z-2204-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Bard* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - recall (Z-2205-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., FASTRAC Guidewire Gastric Access Port Kit, REF 005739, 20F, Ste recall (Z-2206-2009)C.R. Bard Access Systems, Inc2009-09-15
Bard Access Systems, Inc., Bard* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - recall (Z-2207-2009)C.R. Bard Access Systems, Inc2009-09-15