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FDA 510(k)

DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS)

K-Number: K960400 · 1996-03-12

ApplicantSnowden-Pencer
Decision Date1996-03-12
Product CodeFBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS) is the device name listed in this FDA 510(k) record. The listed applicant is Snowden-Pencer. It received FDA 510(k) clearance on 1996-03-12 under 510(k) number K960400. The device is classified under product code FBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS)?

DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS) is a medical device that received FDA 510(k) clearance on 1996-03-12. The listed applicant is Snowden-Pencer. The 510(k) number is K960400.

When did DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS) receive FDA 510(k) clearance?

DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS) received FDA 510(k) clearance on 1996-03-12, under 510(k) number K960400.

Who is the listed applicant for DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS)?

The FDA 510(k) record lists Snowden-Pencer as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS)?

The FDA product code for DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS) is FBM.

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Other records listing Snowden-Pencer as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K930666REUSABLE LAPAROSCOPIC INSTRUMENTS W/ ELECTROCAUTERYK930667REUSABLE LAPAROSCOPIC INSTRUMENTSK924148DIAMOND-SHARP(R) TROCARSK924149ENDO I/A PROBEK920985SNOWDEN-PENCER IRRIGATION PUMPK920986SNOWDEN-PENCER HIGH FLOW INSUFFLATOR, SP/88-9700

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Related Devices (Code: FBM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K932021ENTREE CANNULA FASCIA ANCHORSCore Dynamics, Inc.K911813ENTREE CANNULACore Dynamics, Inc.K900961GS-4100 REDUCER SLEEVE, 5MM TO 3MMSolos Endoscopy, Inc.K900962GS-4300 CANNULA AND TROCAR, 5.5MMSolos Endoscopy, Inc.K900955GS-4000 REDUCER SLEEVE, 11MM TO 5MMSolos Endoscopy, Inc.K900963GS-4350 TROCAR ONLY, 5.5MMSolos Endoscopy, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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